Biocryst
2 products tracked · names used in filings: Biocryst, Biocryst Pharmaceuticals Inc
Upcoming milestones
No upcoming milestones listed.
Recent milestones
Fri 12 Dec 2025🇺🇸 PDUFA datecompany-announced
ORLADEYO: PDUFA target action date (hereditary angioedema (HAE) in pediatric patients aged 2 to 11 years (oral granules))
Biocryst Pharmaceuticals Inc (BCRX); berotralstat; NDA; status: extended; "The new PDUFA target action date is December 12, 2025."; filed 2025-06-25 · source
Thu 11 Dec 2025🇺🇸 FDA approval
FDA approves Orladeyo (berotralstat dihydrochloride): new dosage form
Biocryst; NDA219776; New dosage form, Priority review; pellets · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇺🇸 | Orladeyo berotralstat dihydrochloride | Approved | 2025-12-11 |
| 🇪🇺 | Alpivab peramivir | Withdrawn | 2018-04-13 |
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.